中国药房2016，Vol.27Issue(12)：1713-1715,3.DOI:10.6039/j.issn.1001-0408.2016.12.43
HPLC法测定联苯苄唑原料药中的有关物质
Determination of Related Substances of Bifonazole Raw Material by HPLC
韩春晖 1裘一兰 1栾爽 1耿欣1
作者信息
- 1. 大连市药品检验所,辽宁大连 116021
- 折叠
摘要
Abstract
OBJECTIVE:To establish a method for the determination of related substances in bifonazole raw material. METH-ODS:HPLC method was performed on the column of Kromasil C18 with mobile phase of methanol-0.02 mol/L phosphoric acid(ad-justed pH to 7.5 with triethylamine)(70:30,V/V)at a flow rate of 1.0 ml/min,detection wavelength was 258 nm,volume injection was 20 μl,and the column temperature was 40 ℃. RESULTS:The linear range was 0.05-0.25 μg/ml for bifonazole(r=0.9996), 0.05-0.25 μg/ml for impurity A(bifonol)(r=0.9997)and 0.05-0.25 μg/ml for impurity B(4-C isomer)(r=0.9995);the detec-tion limits were 8.2 ng/ml,7.5 ng/ml and 8.4 ng/ml,and the quantification limits were 27.1 ng/ml,24.7 ng/ml and 27.8 ng/ml,re-spectively;RSDs of precision and reproducibility tests were lower than 1%;recovery of impurity B was 95.13%-101.29%(RSD=1.89%,n=9);both impurity A and impurity B were were detected in the 3 batches of samples. CONCLUSIONS:The method is accurate,sensitive and reproducible,and can be used for the determination of the related substances in bifonazole raw material.关键词
高效液相色谱法/联苯苄唑原料药/有关物质Key words
HPLC/Bifonazole raw material/Related substances分类
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韩春晖,裘一兰,栾爽,耿欣..HPLC法测定联苯苄唑原料药中的有关物质[J].中国药房,2016,27(12):1713-1715,3.
